During the recent 35-day US Government shutdown, the lapse in funding to the FDA was “one of the most significant operational challenges” in the agency’s recent history, according to FDA Commissioner Scott Gottlieb.
After a bumper year of approvals, the agency was forced to put its 2019 budget on hold and grant temporary leave to around 40% of its employees, slowing down the drug approval process and halting administrative activities.
With headlines predicting a second shutdown could be on the horizon, what are the implications of this continued risk, and what may be the likely impact for the FDA and drug approval rates?
Suspended Review of New Drug Applications
As part of its review process, the FDA charges user fees for new drug and device applications. During the recent shutdown, the FDA was only able to support review for certain applications by using carryover user fee balances (funded by fiscal year 2018 user fees). This means it wasn’t legally allowed to collect fiscal year 2019 user fee payments during the shutdown, thus potentially delaying new applications for drugs, generics, biosimilars, and medical devices being reviewed under the User Fee Acts.
For New Drug Applications, Biologics License Applications and Pre-Market Approvals, which have their own product user fee, the FDA stated that companies that had filed and paid the fee could expect the review to continue, although there was a risk that review time frames may slip. However, reviews of existing Investigational New Drug (IND) and Biologics License Application (BLA) not covered by user fees were suspended, and the agency halted review of applications for new drugs and biologics submitted during the shutdown period, except for emergency INDs and BLAs.
Impact of Further Delays in FDA Approval Decisions
Within just a few weeks the impact of these delays is already being felt. Several companies seeking FDA approval are said to have been left in the lurch by the lapse in agency funding. To deal with an ever-increasing backlog, the FDA will need to make some tough decisions on where to place their finite resources, likely focusing on those applications with priority review or urgent medical need. So, for many companies further down the submission queue, there are potentially significant and continued delays, which would surely signal a worse impact for small drug-makers.
Worryingly, during the last shutdown, the FDA stated that funding to review pending drug and biologic applications would run out by early February, and that it would need to shift resources from pre-market drug review to post-marketing safety surveillance. It also halted work on regulatory guidance documents related to medical devices, drugs, and biologics.
Some argue that the time has come for the FDA to be independent from the government. And, as the agency faces what could be its second lapse in funding in less than a month, those of us working in clinical research, trying to deliver much-needed drugs to patients, may be inclined to agree.